EUCTR2008-007149-30-GB进行中（未招募）1 期
Optimal Treatment of Drug Resistant Hypertension - Optimal Treatment of Drug Resistant Hypertension
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 个研究点目标入组 346 人开始时间: 2009年1月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 346
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients aged 18-79 years;
- •Patients will all have hypertension that is not controlled to target: clinic systolic BP = 5 mmHg above target (i.e. = 140 mmHg for non-diabetic hypertensives or = 135 mmHg for diabetics), under one of the following conditions:
- •a) Treatment for at least 3 months with lisinopril 20 mg (A) + amlodipine 10 mg (C)+bendroflumethiazide 2.5 mg (D) or their equivalents‡
- •b) Patients who have received the three drugs or equivalents specified in a), and are either intolerant to one category, or tolerate only a lower dose (e.g. amlodipine 5 mg or lisinopril 10 mg)
- •c) Patients receiving the three drugs or equivalents specified in a), who are receiving additional drugs for their hypertension, may be included if the investigator 1) feels it is appropriate to stop these additional drugs at the screening visit and 2) anticipates that the BP criteria for inclusion will be met when re-checked at the baseline visit
- •Patients may be included if the PI anticipates BP criteria for inclusion will be met at randomisation.
- •3. Patients with a home systolic BP average of >130 mmHg or within 15mmHg of clinic BP over the 4 days prior to the baseline visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Inability to give informed consent;
- •2. Participation in a clinical study involving an investigational drug or device within 4 weeks of screening;
- •3. Secondary or accelerated hypertension;
- •4. Type 1 diabetes;
- •5. eGFR<45 mls/min;
- •6. Plasma potassium outside of normal range on two successive measurements during screening;
- •7. Pregnancy, planning to conceive, or women of child-bearing potential, i.e. not using barrier effective contraception;
- •8. Anticipated change of medical status during the trial (e.g. surgical intervention requiring >2 weeks convalescence);
- •9. Absolute contra-indication to study drugs (e.g. asthma) or previous intolerance of trial therapy;
- •10. Sustained atrial fibrillation;
- •11. Recent (<6 months) cardiovascular event requiring hospitalisation (e.g. myocardial infarction or stroke);
- •12. Suspected non-adherence to antihypertensive treatment (see above);
- •13. Requirement for study drug for reason other than to treat hypertension, (e.g. ß-blockers for angina or diuretics other than those to treat hypertension);
- •14. Current therapy for cancer;
- •15. Concurrent chronic illness, or other reasons likely to preclude 40 week participation in the study;
- •16. Clinic Systolic BP >200 mmHg or diastolic BP >120mmHg, with PI discretion to override if home BP measurements are lower
- •17. Any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or severely limit that patients life-span or ability to complete the study (e.g. alcohol or drug abuse, disabling or terminal illness, mental disorders);
- •18. Treatment with any of the following medications;
- •a. Oral corticosteroids within 3 months of screening. Treatment with systemic corticosteroids is also prohibited during study participation;
- •b. Chronic stable use, or unstable use of NSAIDs (other than low dose aspirin) is prohibited. Chronic use is defined as >3 consecutive or non-consecutive days of treatment per week. In addition intermittent use of NSAIDs is strongly discouraged throughout the study and NSAIDs if required, must not be used for more than a total of 2 days. For those requiring analgesics during the study, paracetamol is recommended.
- •c. The use of short acting nitrates (e.g. sublingual nitroglycerin) is permitted. However, participants should not take
- •P2 Protocol v7.1 26 May 11 Page 14 of 69
- •short acting oral nitrates within 4 hours of screening or an subsequent visit;
- •d. The use of long acting nitrates (e.g. Isordil) is permitted but the dose must be stable for at least 2 weeks prior to screening and randomisation;
- •e. The use of sympathomimetic decongestants is permitted , however, not within 1 day prior to any study visit/BP assessment;
- •f. The use of theophylline is permitted but the dose must be stable for at least 4 weeks prior to screening and throughout the study;
- •g. The use of phosphodiesterase type V inhibitors is permitted; however study participants must refrain from taking these medications for at least 1 day prior to screening or any subsequent study visits;
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